Investigational Product Development
This course provides an overview and summary of the investigational product development process. The course includes information on the different phases of clinical research necessary to file an Investigational New Drug Application (IND) and a New Drug Application (NDA). Topics in this course include: Stages, Trial Phases, Medical Devices, FDA Approval, and Post-marketing. After completing this course, learners will be able to recognize drug development phases and the main purpose of each phase as well as other elements of the investigational product development.
After this course learners will be able to recognize drug development phases as well as the main purpose of each phase. recognize how each phase of new product development contributes knowledge about the safety and/or efficacy of the drug or device. identify key differences between pharmaceutical product and medical device development. recognize factors contributing to the size and expense of trials.